FDA issues guidance for company-issued recall notices

WASHINGTON – The US Food and Drug Administration (FDA) issued new guidance for issuing public warnings and notification of recalls.

The new guidance:

Outlines circumstances when a company should issue a public warning about a recall;

Describes the general timeframe for companies to issue public warnings;

Relates what information should be included; and

Describes situations where the agency may issue its own public warning should a company’s warning be deemed insufficient.

FDA Commissioner Scott Gottlieb said, “Consumers should expect to continue to see more frequent communication on potential risks to their health. We’ll continue to seek out opportunities for improved processes, education and awareness. And we constantly strive to learn from every recall, and every issue, so that we can help to prevent future recalls and to work quickly with companies to remove the products from the market.”

The new guidance is the final installment of protocols aimed at improving communication of public health warnings and product recalls to the public. Previously, FDA issued draft guidance detailing when the agency will publicize retail locations that may have sold or distributed human or pet food that is subject to a recall. In November 2018, FDA also finalized mandatory recall guidance for foods.

Gottlieb noted that product recalls declined in fiscal year 2018 to 7,420 — with 831 classified as the highest risk — which represents a five-year low in recalls. He added that “…the reason why recall notices might seem to have increased is that our publicizing of these events has become more prominent. We’re routinely providing more information on recalls and other safety issues that have happened. We’ve also been communicating more frequently and, in many cases, directly to consumers through the agency’s social media. I believe that it’s critical for consumers to have this information so that they can take an action to protect their own health.”

Additional steps the agency is taking to modernize communication to consumers includes engaging new technologies that might be used to provide information to consumers. FDA also is testing technology that screen for multiple allergens simultaneously and devices that reduces genetic testing devices to sizes smaller than smartphones. FDA also is working to improve product traceability through the use of blockchain technology, Gottlieb said.

“Our ability to detect, track and trace potential or known problems with products continues to improve as we implement new technologies across the agency and as companies implement their own technological advances throughout their supply chains.” Whole Genome Sequencing — a kind of DNA fingerprinting — has allowed federal, state and local health officials to detect related illnesses, match them more often with a food product, facility or environment, and trace the contamination to the source.